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510(k) K153769

R:GEN Laser System by Lutronic Corporation — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2016
Date Received
December 30, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Ophthalmic
Device Class
Class II
Regulation Number
886.4390
Review Panel
OP
Submission Type

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